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NCT Number: NCT06019169

Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is often accompanied by anxiety and depression symptoms that can contribute to poor treatment compliance. The overall management of heart failure is currently part of the recommendations and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is an ancient practice, known to improve the emotional and physical well-being of individuals. There is no formal medical contraindication to this practice, which can be perfectly adapted to the patient's condition. However, very few patients with heart failure practice yoga. A few randomized trials with small numbers as well as the combined analysis of several studies have shown the benefit of yoga in heart failure. The main objective of the research is to demonstrate the improvement in the quality of life induced by the regular practice of yoga in the management of stabilized chronic heart failure patients. Secondly, we will evaluate the effectiveness of regular yoga practice on improving the clinical condition of chronic heart failure patients.

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC

Paris, 75013, France

Location status: Recruiting

Location contact

Gilles MONTALESCOT, Pr

CONTACT

[email protected]

01 42 16 30 07 ext. 0033

About this study

Study design :

Pilot study, prospective, monocentric controlled in open, Randomization ratio 1:1: in two parallel groups

  • Arm control workshops around social activities
  • Yoga arm (Y): Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed at each session.

Population concerned :

Patients with stabilized chronic heart failure (last episode of acute heart failure dating back more than a month) followed at the Pitié Salpêtrière cardiology institut

The study may be offered to any stabilized heart failure patient followed in the study centre. Visit V1 (D0): Information, Inclusion and randomization Visit V2 (M3): final visit. Between V1 and V2: weekly workshop sessions around storytelling (arm C) or Hatha yoga (Arm Y).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient ≥18 years old
  • Chronic heart failure patient defined by: Most recent LVEF ≤50% (regardless of measurement method)
  • Stabilized (last episode of acute heart failure dating back more than a month) in NYHA stage I to III dyspnoea, ambulatory, discharged from hospital for > 1 month
  • Drug treatment optimized according to the judgment of the investigator
  • Ability to participate in activities as proposed (remote or face-to-face)
  • Patient affiliated with a social security scheme
  • Written consent to participate

Exclusion criteria

  • Patients who have practiced yoga regularly (> once a month) in the six months prior to selection.
  • Current pregnancy / lactation
  • Etiology of heart failure: hypertrophic cardiomyopathy, restrictive heart disease or severe curable valve disease
  • Severe renal impairment GFR<25ml/min/1.73 m2 or on dialysis.
  • Persons subject to legal protection measures (guardianship, curatorship)
  • Person not "receptive" to the practice of yoga
  • Participation in intervention research

Treatment and study plan

Yoga arm

Other

Participation in YOGA classes performed by Mme Laura BOGANI from The Blue Fish LAB Association. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed at each session.

storytelling activities

Other

Participate in workshops around storytelling led by the association of storytellers l'Age D'or. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months. An attendance sheet will be completed at each session.

Primary outcomes

  1. SF-36 quality of life

    Time frame: at day 0 and maximum at 5 month

    The SF-36 quality of life self-questionnaire is one of the most widely used questionnaires to assess the quality of life of patients. Its result is between 0 and 100. It includes a physical summary score and a psychological summary score.

Secondary outcomes

  1. Score Hospital Anxiety and Depression Scale (HAD)

    Time frame: at day 0 and maximum at 5 month

    Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome

  2. Weight (kg)

    Time frame: at day 0 and maximum at 5 month

    Weight measurement during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.

  3. Waist circumference (cm)

    Time frame: at day 0 and maximum at 5 month

    Measurement of the waist circumference during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.

  4. Heart rate (Bpm)

    Time frame: at day 0 and maximum at 5 month

    Measurement of the heart rate during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.

  5. Blood pressure (mmHg)

    Time frame: at day 0 and maximum at 5 month

    Measurement of blood pressure during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.

  6. NYHA assessment

    Time frame: at day 0 and maximum at 5 month

    Definition of the stage of heart failure by the NHYA classification at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.

  7. Concentration of Nt-pro BNP Biomarker

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    Analysis of Nt-pro BNP biomarkers at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center

  8. Concentration of CRP Biomarkers

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    Analysis of CRP biomarkers at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center

  9. Concentration IL6 Biomarkers

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    Analysis of IL6 biomarkers during the inclusion visit (1st visit) and the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center

  10. Distance during 6-minute walk test

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    distance traveled by the patient in 6 minutes

  11. Peak VO2

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    Peak VO2 measurement on two different dates to analyze the results of walk tests carried out according to the center's current practice

  12. VO2 charge level

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    VO2 charge level on two different dates to analyze the results of walk tests carried out according to the center's current practice

  13. VE/VCO2

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    Measurement of the VE/VCO2 ratio on two different dates to analyze the results of the walk tests carried out according to the current practice of the center

  14. First ventilatory threshold

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    Measurement of the first ventilatory threshold on two different dates to analyze the results of the walking tests carried out according to the current practice of the center

  15. First ventilatory load level

    Time frame: 3 months before inclusion and maximum 7 months after inclusion

    Measurement of the first ventilatory level of load on two different dates to analyze the results of the walking tests carried out according to the current practice of the center

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LEGRAND, Dr

CONTACT

[email protected]

01 42 16 30 74 ext. +33

Nicolas VIGNOLLES

CONTACT

[email protected]

01 42 16 30 30 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Randomized Pilot Trial: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

Acronym: YOG-IC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 31, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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